Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose

Maria Katharina Schweitzer, Manuel Nico Dold, Astrid Genet, Klaus Gossens, Thomas Klein-Hessling, Nils Löffler, Matthias Rabel, Andrej Rasch, Eva-Maria Reuter, Jessica Schmelcher, Natalia Wolfram and Sebastian Werner ()
Additional contact information
Maria Katharina Schweitzer: AMS Advanced Medical Services GmbH
Manuel Nico Dold: AMS Advanced Medical Services GmbH
Astrid Genet: Pfizer Deutschland GmbH
Klaus Gossens: AbbVie Deutschland
Thomas Klein-Hessling: AMS Advanced Medical Services GmbH
Nils Löffler: Pfizer Deutschland GmbH
Matthias Rabel: AMS Advanced Medical Services GmbH
Andrej Rasch: Verband Forschender Arzneimittelhersteller e.V.
Eva-Maria Reuter: AMS Advanced Medical Services GmbH
Jessica Schmelcher: AMS Advanced Medical Services GmbH
Natalia Wolfram: AbbVie Deutschland
Sebastian Werner: Verband Forschender Arzneimittelhersteller e.V.

The European Journal of Health Economics, 2024, vol. 25, issue 5, No 10, 877-888

Abstract: Abstract From 2025, Health Technology Developers (HTDs) have to submit EU HTA dossiers. The joint clinical assessment (JCA) aims to streamline HTA processes and access to medicinal products across Europe. Currently, German HTA bodies IQWiG and G-BA actively shape the JCA methodology. Here we examine if German HTA dossier requirements are suitable for the JCA. We compare the number of safety endpoint and subgroup analyses in German dossiers with analyses considered in IQWIG’s benefit assessment and evaluate if these analyses were considered by the G-BA. We further investigated how the number of analyses was affected by the latest change in the German dossier template. With the current template, HTDs report in median 2.6 times more analyses on adverse events (AE) and 1.1 times more subgroup categories than in the previous template. IQWiG does not consider 33% of AE analyses and 73% of the subgroup categories presented by the HTD under the current template. G-BA considered the same AE as IQWiG in 76% of cases. Subgroups were uncommented by G-BA in most cases, independent of the template (previous: 93%, current 85%) and unconsidered in the conclusion on additional benefit (previous: 77%, current 69%). Thus, changes in the dossier template drastically increased HTD workload, but additional analyses seem unconsidered by the HTA bodies. With a broader scope in JCA, this effect could be amplified. To mitigate duplicative efforts and ensure prompt availability of medicinal products as envisioned by the HTAR, we suggest well-chosen and precise dossier requirements, early consultations, and early HTD engagement.

Keywords: AMNOG; IQWiG; G-BA; EU HTA; PICO; JCA (search for similar items in EconPapers)
JEL-codes: I10 I18 (search for similar items in EconPapers)
Date: 2024
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DOI: 10.1007/s10198-023-01631-5

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